Kornimate/medical-research-clean huggingface dataset:
magic aki: magnesium for the prevention of hioc-associated aki

Conditions: Mesothelioma

Summary: in this research study, investigators will test whether prophylactic high-dose iv mg administration attenuates the risk of aki in patients with malignant mesothelioma receiving intraoperative chemotherapy (hioc) with cisplatin compared to placebo .

in this phase 2, open-label randomized, placebo-controlled trial, investigators will test whether prophylactic high-dose iv mg administration attenuates the risk of hioc-associated aki in patients with malignant mesothelioma undergoing surgery with hiocc. investigators will randomly assign 130 patients to receive iv mg versus an equal volume of normal saline (0.9% ns) placebo, of whom it is anticipated 80 will complete the study. investigators will also collect blood and urine pre- and postoperatively for exploration of secondary outcomes. investigators will screen for eligibility at participant's preoperative visit with their thoracic surgeon. intravenous magnesium will be administered as a continuous infusion, soon after induction and stabilization by anesthesia in the operating room. the magnesium drip will start at 1 g/hour and will be titrated to achieve target levels of 3-5 mg/dl. the total duration of the infusion will be 24 hours.

Eligibility criteria:
inclusion criteria: 1. • adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with hioc with dr. raphael bueno or another bwh thoracic surgeon exclusion criteria: 1. egfr\<45 ml/min/1.73m2 on either screening labs or preoperative labs, or end-stage kidney disease receiving renal replacement therapy. screening labs refer to those obtained at the preoperative visit with the surgeon or within 90 days prior, whereas preoperative labs are obtained on the day of admission (typically one to three days priors to surgery). 2. serum mg \>3 mg/dl on either screening labs or preoperative labs 3. pregnant/breastfeeding 4. neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myositis) 5. coronary artery disease, defined as any of the following in the prior year: a positive stress test; coronary angiogram indicating 1 or more vessels with \>70% stenosis; percutaneous coronary intervention with stents; or coronary artery bypass graft surgery 6. sinus bradycardia, defined as a heart rate (hr) \<55 beats per minute (bpm) detected on any ecg in the preceding 6 months 7. high grade av block (2nd degree av block type ii or 3rd degree av block) without a pacemaker 8. positive covid test in the 10 days prior to surgery 9. prisoner 10. hypersensitivity to mg sulfate 11. concurrent participation in a study with an alternative experimental therapy that may interact with iv mg 12. any condition that, in the view of the pi, might place the patient at increased risk or compromise the integrity of the study 13. conflict with other study

Keywords: mesothelioma magnesium sulfate intraoperative cisplatin
surgery for pancreatic cancer with oligo-metastasis

Conditions: Pancreatic Cancer; Pancreatic Surgery

Summary: pancreatic cancer is increasing in incidence and will be the second leading cause of cancer-related deaths in 2030 in the west. only 10 to 15% of patients are eligible for curative resection with long-term survival rarely exceeding 20% at 5 years. the management of metastatic or recurrent diseases can not, unfortunately, be recommended to date because of limited data available (inca 2019). however, recent, low-strength publications have reported encouraging results on the long-term survival of stage iv or recurrent patients. the aim of the present retrospective cohort study is to analyze results of surgery/destruction of metastatic synchronous or metachronous disease or local recurrence in patients with stage iv pancreatic cancer


Eligibility criteria:
inclusion criteria: - patients who had resection or destruction of one or more synchronous or metachronous metastases or local recurrence of pancreatic adenocarcinoma details: * synchronous lesions, metachrones can be included * all distant lesions (hepatic, pulmonary) can be included * documented lymph node involvement after analysis of the specimen (hepatic hilum, mesenteric root, retroperitoneal or inter-aortic-cellar) can be included * patients with local recurrence who underwent surgical treatment exclusion criteria: - patient who reject the study protocol

Keywords: surgery metastasis surgery survival multimodal treatment stage iv
neonatal antimicrobial resistance and outcome

Conditions: Neonatal Infection

Summary: this is a multicentre observational study involving nnus across the uk. study personnel (neonatologists and research nurses) from these nnus will identify eligible babies in whom a positive culture has been obtained. this study will help identify the infections leading to death in babies on uk neonatal units, define the clinical characteristics of babies dying from infections, and describe the management of babies dying from infections with a specific focus in their antimicrobial treatment.

the neonin surveillance network captures data on episodes of invasive neonatal infection on a web-based database. over 30 uk neonatal units currently contribute to this database in real-time. an episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (csf) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire. denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit. through our study we aim to understand and describe better those infections and risk factors that lead to death. the case-control study will enable us to determine if gaps in optimal management, such as the wrong antibiotic or the wrong dose, are associated with poor outcomes. we can then translate such information into practice and develop / improve clinical guidance in order to improve outcomes. for the purpose of this study, we will request information on the baby's status (alive/died/not known) at 28 days after the positive culture was obtained. if the baby is alive, then this baby becomes eligible as a control. if the baby has died, then further details will be sought including the date of death and whether death was attributed to the infection.

Eligibility criteria:
inclusion criteria: • infants on participating nnus who have an episode of infection with a positive culture.

Keywords: infection
a computer-based cognitive stimulation in mild cognitive impairment with white matter hyperintensities

Conditions: Mild Cognitive Impairment

Summary: this is a non-pharmacological study evaluating the impact of a computerized cognitive stimulation program on verbal learning and on the progression white matter hyperintensities in elderly with mild cognitive impairment.

white matter hyperintensities (wmh) can appear in mild cognitive impairment (mci) and have been associated to executive, attention and processing speed deficits. some findings indicate that the presence of wmh may contribute to alzheimer's disease (ad) in addition to ß-amyloid, suggesting a greater vulnerability of mci. one important challenge is to prevent or slowing down the progression of wmh. few studies investigated the effects of computerized cognitive interventions in mci with wmh, which deserve special attention. this study aim to investigate the effects of an intensive computer-based cognitive stimulation (ccs) program on the verbal learning in episodic memory in mci with wmh and to explore the effects on the progression of wmh at 1-year interval.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild cognitive impairment * with and without with matter hyperintensities * mri data available or accept to perform one * no engagement in other cognitive intervention program exclusion criteria: * psychiatric and neurological disorders * history of alcohol or other substance consumption * sensory and or motor deficit that could interfere with the use of computer tool * refusal mri.

Keywords: mild cognitive impairment white matter hyperintensities computerized cognitive training brain plasticity
appropriateness of carpal tunnel syndrome management compared with the aaos appropriate use criteria

Conditions: Carpal Tunnel Syndrome

Summary: purpose: carpal tunnel syndrome (cts) is a common peripheral nerve entrapment disorder among adults that causes upper-extremity disability. the american academy of orthopedic surgeons (aaos) developed an evidence-based appropriate use criteria (auc) for the management of cts. this study aims to assess the appropriateness of our practice and the usability of the auc by comparing the actual management provided at our institution with that recommended by the auc. methods: a retrospective review of the electronic medical records at our hospital will be performed between 1 jan 2016 and 31 dec 2019. data will be collected by two authors independently. the collected data will be input into the auc application to determine the rate of the appropriateness of the treatments. afterwards, the agreement between the actual treatment provided and the auc recommendation will be assessed. the primary outcome will be the appropriateness rate. descriptive statistics such as the mean, range and percentage will be used to summarize the patients' demographics and treatment options. results: the appropriateness rating (appropriate, maybe, or rarely appropriate) for each treatment will be described with percentages. similarly, the agreement of the treatments implemented at our institution with the auc recommendations will be expressed as a proportion. a subgroup analysis within the same cohort compared the appropriateness rates of surgical release of patients across different surgical specialties using chi2 test. conclusion: this study will show if the management provided at our institution were appropriate and in agreement with the auc recommendations. additionally, it will test the usability of auc for carpal tunnel syndrome as a valuable and practical tool that can be applied in clinical settings.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) who were diagnosed with cts. exclusion criteria as per the auc: * acute carpal tunnel syndrome * untreated inflammatory arthritis * untreated diabetes * thyroid disease * pernicious anemia * patients with a known space-occupying lesion in the carpal tunnel * failed treatment after surgery * pediatric and adolescent patients

Keywords: carpal tunnel syndrome management hand surgery
an open-labeled exploratory study to evaluate safety and efficacy of fb825 in adults with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the safety and efficacy of fb825 in adults with atopic dermatitis

this is an open-labeled exploratory study to evaluate safety and efficacy of fb825 in adults with atopic dermatitis (ad). the study will be conduct at one medical center in taiwan. approximately 12 subjects with atopic dermatitis (ad), who meet the criteria for study entry, will be enrolled to the one-arm-study.

Eligibility criteria:
inclusion criteria: 1. male or female subjects between 20 and 65 years of age, inclusive. 2. the subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on 3 years history of symptoms defined by the eichenfield revised criteria of hannifin and rajka and supported by positive allergen-specific ige at the screening visit. 3. eczema area and severity index (easi) score ≧14 at the screening and baseline visits. 4. investigator's global assessment (iga) score ≧ 3 (5-point scale) at the screening and baseline visits. 5. ≧10 % body surface area (bsa) of ad involvement at the screening and baseline visits. exclusion criteria: 1. female subjects who are pregnant or lactating. 2. the subject is on diet or with poor intake. 3. the subject has a history of heart arrhythmias (any clinically relevant). 4. the subject has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening. 5. the subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
vagal nerve stimulation and pain frequency, intensity in chronic migraine

Conditions: Migraine

Summary: this study is being conducted to address the need for effective and well-tolerated interventions in preventing chronic migraine attacks. chronic migraines significantly impact the quality of life for individuals suffering from them, often leading to substantial discomfort and impairment. by evaluating the feasibility, safety, and acceptance of noninvasive vagus nerve stimulation (nvns), researchers aim to determine if this approach can offer a viable solution for alleviating the frequency and severity of chronic migraine episodes. if successful, this study could potentially introduce a promising new treatment option that enhances the well-being and daily functioning of those affected by chronic migraines.

neuromodulation is a growing field in headache management. technology ranges from invasive deep brain stimulation (dbs) of the posterior hypothalamus, to minimally invasive percutaneous electrode implantation for occipital nerve stimulation, and noninvasive transcranial magnetic stimulation and transcranial direct current stimulation. neurostimulation can be particularly useful to those who failed triptans or other prophylactic treatments. the european headache federation positioned that a neurostimulation device should only be used in medically intractable headache patient who has been evaluated at a tertiary headache center. vagus nerve stimulation (vns), which has demonstrated its antinociceptive potential, may also provide a relief of pain associated with headache

Eligibility criteria:
inclusion criteria: * chronic migraine (headache for 15 or more days/month for more than three months), migraine with/without aura exclusion criteria: * mental illness, photophobic individual, presence of shunt and/or implant at the cranial region

Keywords: chronic migraine vagal nerve stimulation pain intensity and frequency
comparison of educational methods for teaching peripheral blood smears

Conditions: Hematologic Diseases

Summary: this is a prospective, randomized controlled, crossover trial comparing the effectiveness one two curricular designs to teaching peripheral blood smears to residents.

general approach: this study will employ a randomized, controlled design and will use as its outcomes two separate post-tests, one after the first teaching session and one 4 weeks after the second intervention. design the investigators are attempting to find whether the combination of basic science education using an 1-hour additive microskills- building method along with compare/ contrast model versus a 1-hour traditional case-based format would improve performance on a visual recognition test of hematology questions. a final test at 4 weeks after the cross-over between the two groups will also help investigators analyze whether the order of exposure to the teaching method would have an impact on the final performance. sampling, including sample size and statistical power: sample size will be between 40-50 resident physicians meeting inclusion criteria for the study. there is not enough data in the literature to effectively determine power, so we will use a convenience sample of the largest feasible group (around 40). collection of data: data will be collected on an excel spreadsheet and will be permanently de-identified on that spreadsheet; it will be kept on a password-protected site. information management and analysis software: data will be entered into a password protected excel spreadsheet and each study participant will be assigned a unique identifier code which will be used to link the data. statistical analysis will be performed using spss version 20. data entry, editing and management, including handling of data collection forms, different versions of data, and data storage and disposition: paper surveys and tests will be collected, recorded and locked; they will be destroyed 2 years after termination of the study. a paired t-test will be used to compare the two samples means for significance. quality control / assurance: pretest and post-tests will be checked against a gold standard, a hospital board-certified hematopathologist, to check the quality of the slides. bias in data collection, measurement and analysis: given the small numbers of participants expected, a type 1 error (failure to detect a difference in groups when one exists) is possible, as the study will possibly be underpowered.

Eligibility criteria:
inclusion criteria: * internal medicine and family medicine residents and faculty at the reading hospital and medical center having completed medical school exclusion criteria: * practicing/ board certified hematologists

Keywords: education
effects of eccentric training intervention in older adults

Conditions: Sarcopenia

Summary: sarcopenia leads to loss of muscle mass and muscle strength during the aging process. it has been reported that eccentric training has some positive effects on the preservation of eccentric strength, with less delayed onset muscle soreness (doms) in older groups, and lower metabolic costs.

this is prospective study. the goals of this study are to: 1. examine the effects of eccentric training on physical function (gait speed, stair climb, chair stand) in older adults. 2. examine the effects of eccentric training on muscle strength (isometric strength, isokinetic strength, power) in older adults.

Eligibility criteria:
inclusion criteria: * subjects who can agree voluntarily * older men/women: age (60 - 80 yrs) exclusion criteria: * uncontrolled hypertension * acute coronary syndrome * subjects who took drugs which can affects neuromuscular system * subjects who cannot agree voluntarily

Keywords: aging eccentric training muscle strength physical function sarcopenia
an extension to study malaria-055 pri (nct00866619) to evaluate the long-term efficacy, safety and immunogenicity of gsk biologicals' candidate malaria vaccine in infants and children in africa

Conditions: Malaria

Summary: the purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the gsk biologicals rts,s/as01e candidate plasmodium falciparum malaria vaccine in infants and children in africa following a primary vaccination series (nct00866619). no new subjects will be enrolled in this extension study.


Eligibility criteria:
inclusion criteria: * subjects' parent(s)/ legally acceptable representative (lars) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * subjects who were enrolled and who received at least one vaccine dose in the primary study malaria-055 pri nct00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study malaria-055 pri nct00866619. * written informed consent obtained from the parent(s)/lar(s) of the subject. exclusion criteria: * child in care. * use of any investigational or non-registered product or planned use during the study period.

Keywords: infants efficacy children malaria plasmodium falciparum safety surveillance immunogenicity rts,s/as01e africa
female urethral catheterization - instillation of the lubricating gel into the urethra or pouring it on the catheter's tip?

Conditions: Pain

Summary: currently, there are no specific guidelines or best practice suggestions for female catheterization. however, there is a consensus that an anesthetic lubricating gel should be routinely used in women as well. urethral lubrication can be performed in two different techniques: instillation of the gel directly into the urethra or pouring the gel on the catheter's tip. in this study, we will evaluate the pain level during female urethral catheterization in each technique. our hypothesis is that the level of pain will be much less if the lubrication agent will be instilled directely to the urethra.

this is a randomized prospective study that will compare the pain levels of urethral catheterization in women randomized to intraurethral lidocaine gel instillation or lubrication of the catheter's tip with lidocaine gel. women aged 18 years and older who will be referred for multichannel urodynamic study in order to evaluate lower urinary tract symptomswill be included. patients will be randomized to 2 groups: (1) 5ml of 2% lidocaine gel instilled directly into the urethra 5 minutes before catheterization; (2), 5ml of 2% lidocaine gel poured on the distal part of the catheter. the randomization technique will be employed by a computerized random number generator. a 12f nelaton urethral catheter will be introduced in order to measure post-void residual volumes. subsequently, multichannel urodynamic testing (duet encompass system - mediwatch group plc) will be performed using a dual lumen 6f urethral and 9f rectal catheters. filling will be carried out using room temperature saline at a filling rate of 50 ml/min. patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual analog pain scale (vas) in different time points: prior to gel instillation (baseline), immediately after gel instillation (only in group 1), immediately after the introduction of the nelaton catheter, 5 and 30 minutes after the catheter will be taken out. time frame of the study: 30 minutes before the test and 1 hour after the test. since the study evaluates pain during the procedure the time frame of the study and assessment is very short. longer follow-up is not needed.

Eligibility criteria:
inclusion criteria: women aged 18 years and older who will be referred for multichannel urodynamic study in order to evaluate lower urinary tract symptoms. - exclusion criteria: use of any analgesics within the previous 24 hours, known urethral stricture, active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis), known allergy to lidocaine or inability to cooperate with pain assessment due to mental disorders. -

Keywords: pain urethra catheter